Benin medical device regulations

Complete four-page ABMed decision signed 30 April 2026, including health-product regulatory service fees and specific medical-device and medical-equipment services. Article 6 takes effect on signature and repeals contrary earlier provisions. The original fee tables and currency amounts are retained.

Complete signed two-page amendment revises Article 2 of Decree 2024-1295 to allow commercial companies authorised by the health minister to import and distribute non-sterile medical devices wholesale. Also inserts Article 12 bis concerning cosmetics and nutritional supplements. Effective on signature; retain with the original decree. Article 2 also gives non-pharmaceutical commercial companies one year from signature to cease sterile-device or laboratory-reagent imports; that transition runs through December 2026.

Complete 42-page official inspection guideline, version 1, with the stated application date 13 November 2025. Covers inspection planning, good-practice categories, inspection findings, corrective actions and complaints across regulated health-product establishments. Includes medical-device quality-system and clinical-investigation references. The separate signed adoption decision is retained as its own instrument.

Complete ABMed adoption decision signed 13 November 2025. Establishes the implementing inspection guidelines; the retrieved decision does not include the separate guideline annex. That annex remains an explicit acquisition requirement, rather than being treated as present in this document.

Complete twelve-page official guideline, version 1, applied from 3 November 2025, on accelerated, reliance, abbreviated and collaborative authorisation pathways. The guideline defines health products to include medical devices. Eligibility and documentation remain pathway-specific, and medicine- or vaccine-specific provisions are preserved without extending them to every device.

Complete eleven-page official guideline on refusal, suspension, withdrawal, cancellation and expiry of marketing or commercial authorisations, version 1, applied from 3 November 2025. The guideline's health-product definition expressly includes medical devices. Includes the final voluntary-withdrawal/suspension letter template; product-specific fields remain as written in the original.

Official 22-page emergency-use-authorisation guideline, version 1, with the stated application date 3 November 2025. The defined health products expressly include medical devices; the request-letter template specifically includes DMDIV information. Preserves the final annex and reference pages. Section 6.1 names a pre-submission meeting form without reproducing that form, so the guide alone does not supply every referenced application form.

Complete sixteen-page official good-review-practices guideline, version 1, applied from 3 November 2025. Governs evaluation quality, conflicts of interest, confidentiality, communication and review strategy for medicines and other health products; the product definition expressly includes medical devices, laboratory reagents and diagnostic products. Covers initial applications, renewals and variations as general review practices rather than a device-specific change-classification table.

Complete ABMed decision adopting marketing/commercialisation authorisation guidance, emergency-use, fast-track/reliance and variation guidance. Its preamble expressly cites the device homologation Decree 2024-1298. The underlying individual guidelines remain separate required originals.

Complete signed 15-article ABMed decision on quarantined imported health products, including controls, release, non-conformity handling and responsible directorates. Applies within the broad health-product framework, including the separately regulated medical-device import sector.

Complete ABMed decision signed 29 September 2025 adopting ordinary and emergency clinical-trial guidelines for health products. The separate annexes are referenced but are not included in this decision PDF and remain to be retrieved.

Full 114-page official clinical-trials guideline, version 1, applied from 12 September 2025. Section III specifically governs medical devices and diagnostic products, with applications, exemptions, dossier contents, ISO requirements and investigational imports. Device trials follow Sections I and III, while the medicine-specific Section II is not described as a device dossier requirement. The original annex pages are preserved; some named annex forms are referenced without their body and are supplied separately where available.

Complete nine-page official emergency clinical-trials guideline, version 1, applied from 12 September 2025. Requires the normal clinical-trials submission format under EC-LD-0001 and provides accelerated review, ethical and joint-review arrangements during public-health emergencies. The general trial provisions complement the device and IVD scope of the main guideline; this document does not create a separate device dossier format.

Official 26-page licensing guideline, version 1, with the stated application date 14 August 2025. Covers establishment licensing, responsible pharmacists, inspections, major and minor changes, suspension and appeals; its definition of health products expressly includes medical devices and laboratory reagents. The final page lists application-form annexes but does not reproduce those forms; the guide alone does not supply the referenced annexes.

Complete ABMed decision adopting establishment licensing guidelines, signed 14 August 2025. The stand-alone decision is preserved; the attached operational guidelines are a separate unresolved reference and are not represented as included here.

Complete 25-page official import/export guideline, version 1, including the final fee-table annex. Expressly covers medical devices, equipment and laboratory reagents, including special authorisation for unregistered products and GUCE submission procedures. Read with Decree 2024-1295 as amended by 2025-785 and the later 30 April 2026 fee decision; the 2025 annex is not represented as a current consolidated tariff. Native table layout is retained to preserve the association of fee amounts and weight bands.

Complete 49-page official post-marketing quality-surveillance guideline, version 1, with the stated application date 13 August 2025. Covers sampling, laboratory testing, investigation, alerts, quarantine and recall across health products, including in-vitro diagnostic-device labelling and visual inspection. Preserves the surveillance flowchart and the final reference pages; medicine-specific methods are not described as universal device-testing requirements.

Complete signed five-page original decree on the functions, qualifications, authorisation, powers and responsibilities of radiation-safety, nuclear-security and safeguards inspectors. Complements the authority's inspection regime for relevant radiological medical facilities and activities. Takes effect on signature and repeals contrary provisions.

Complete signed 82-page original decree, including all 314 articles and the final ministerial signatures. Governs radiation generators and sources, authorisation, supplier and licensee duties, occupational and public exposure, medical exposures, commissioning, modification, safety and decommissioning. Applies to relevant radiological medical equipment in addition to the general device regime. Article 314 takes effect on signature, repeals the specified 1956 X-ray/radium worker-protection decree and contrary prior provisions; this is the actual 2025 text rather than an older radiation checklist.

Complete signed 67-page original decree, comprising all 71 articles, ministerial signatures and Annexes I–X. Governs radioactive-material transport safety, classification, packaging, consignor/carrier duties, approvals, transport documents and radiation-protection programmes, including relevant medical-source shipments. Article 71 takes effect on signature and repeals contrary provisions. This safety instrument is distinct from the 2023 transport-security decree, which is also retained.

Complete nineteen-page signed decree, including all 58 articles and the final published pages. Identifies radiological installations subject to decommissioning and governs the plan, responsibilities, financing, execution, records and regulatory release. Applies to relevant medical radiological installations throughout the end of their operating life.

Complete eleven-article Presidential decree and signatures, five physical pages, governing clinical trials of health products. Requires local representation for foreign sponsors, dossier review, technical and ethics assessments, authorisation, supervision and changes. The separate implementing clinical guidelines remain distinct documents.

Complete original Presidential decree governing import, export and wholesale/retail distribution of non-medicine health products, expressly including sterile devices, medical equipment and reagents. Article 2 was subsequently amended and Article 12 bis inserted by Decree 2025-785; this 2024 expression is not a consolidated current text.

Complete signed 14-page original decree governing manufacture, export, repackaging and wholesale of medicines and other health products under the pharmaceutical-establishment regime. Takes effect on signature and repeals contrary provisions. Retained as a supply-chain establishment instrument referenced by the licensing framework; establishment requirements apply according to operator type and are not represented as a universal requirement for every device manufacturer.

Complete signed 15-page original decree governing pharmaceutical wholesale establishments and depositories buying, importing, storing and distributing medicines and other health products. Takes effect on signature and repeals contrary provisions. Retained as a supply-chain establishment instrument referenced by the licensing framework; establishment requirements apply according to operator type and are not represented as a universal requirement for every device manufacturer.